BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sealant, Polymerizing

    PMA: P100030 · Supplement: S002 · Decision Nov 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Sealant, Polymerizing
    Trade Name
    ARTERX SURGICAL SEALANT,
    PMA Number
    P100030
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    NBE
    Generic Name
    Sealant, polymerizing
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 5, 2013
    Date Received
    September 3, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO EXTEND THE SHELF LIFE FOR ARTERX SURGICAL SEALANT FROM 12 MONTHS TO 24 MONTHS WHEN STORED AT2-8C AND TO EXTEND THE SHELF LIFE FOR THE ARTERX DELIVERY TIPS FROM 12 MONTHS TO 42 MONTHS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NBE Sealant, Polymerizing